Official Title
Exploration of DNA Methylation as a Marker for Early Detection of High Grade Serous Epithelial Ovarian Cancer
Brief Title
Exploration of DNA Methylation as a Marker for Early Detection of High Grade Serous Epithelial Ovarian Cancer
Protocol ID
NCT03622385
Lead Sponsor
Baylor Research Institute
Brief Summary
The purpose of this study is to determine if there are markers in plasma that can be used
to develop a diagnostic panel for early detection and diagnosis of high grade serous
epithelial ovarian cancer.
Detailed Description
This study has two phases: "Discovery" cohort and "Validation" cohort.
The "Discovery" phase of this study will obtain tissue samples in a retrospective manner.
The investigators will perform genome-scale DNA Methylation analysis to obtain a panel of
candidate methylated DNA biomarkers. Twenty archival primary serous epithelial ovarian
cancer and twenty archival normal ovarian and salpingeal tissues will be identified by
running a report of diagnosis.
During the "Validation" phase of this study, blood and tissue samples will be obtained in
a prospective manner. The patients will be undergoing consultation for undiagnosed pelvic
mass and are being scheduled for a diagnostic laparoscopic biopsy. At the time of their
consultation, patients will be recruited and consented for this phase of the study.
Study Period
-
Enrollment Count
10 participants
Eligibility Criteria
Inclusion Criteria:
- Female
- 18 years of age and older
- Women with an undiagnosed pelvic mass who need to undergo diagnostic laparoscopic
surgery
Exclusion Criteria:
- Male
- Under 18 years of age
- Women who can not give informed consent
Filters
Epithelial Ovarian Cancer
COMPLETED
ADULT
OLDER_ADULT